Continuous Quality: FDA’s Goal for the Case for Quality Program

About five years ago, when FDA started looking at the number of recalls and warning letters to medical device manufacturers, the agency realized that no matter what it seemed to do to try and make things better from a compliance perspective, those numbers weren’t changing. It determined that something different needed to be done, and so it devised the Voluntary Medical Device Manufacturing and Product Quality Pilot Program, within its Case for Quality platform.

“I would say one of the key benefits of the program is that it identifies improvements that companies can make that go beyond straight compliance to the regulations,” panelist Al Crouse, senior director of quality assurance and quality systems at CVRx, told MD+DI. “And that’s not only product quality improvements, but also business process improvements,” he said.

FDA offers significant incentives to companies that sign up for the voluntary program, said both Crouse and copanelist, Mark Rutkiewicz, vice president of quality at Innovize and founder of Consiliso.

“The program is: let’s stop using the stick; let’s start using a carrot,” Rutkiewicz said, adding that as long as companies are in good standing, they can be a part of the program. They sign up with CMMI to have an assessment done, and then FDA will stop its standard quality inspections, he said.

“That’s a very big deal,” says Rutkiewicz.

And the benefits to companies can increase over time. “If you stay on this program, FDA will then give you other incentives, like your 30-day notices will be approved immediately. You won’t need a pre-PMA inspection for your PMA products. So, FDA is basically saying ‘Since you were good and you’re continually improving, then we won’t have to look at you. You can keep on the continuous improvements path.’ You don’t actually have to achieve a certain level—you just have to be working on making improvements,” Rutkiewicz said.

“That’s what Case for Quality is about—continuous improvement,” he said.

The presentation will also feature a discussion of each company’s experiences in the pilot program and what they have learned from it. Rounding out the panel, which is moderated by Becky Fitzgerald, principal and cofounder of Two Harbors Consulting, is Joe Friedrich, quality director at Boston Scientific.

“Anybody who’s interested in improving in medical device quality, as well as business performance, should attend this session,” said Crouse. Rutkiewicz agreed, saying that not only quality professionals, but those in smaller companies, even owners and investors, would benefit from learning more about the program.

"Using the FDA's Case for Quality to Reduce Production Inefficiencies" will be presented at MD&M Minneapolis on Wednesday, October 31, from 1:30 to 2:15 p.m.